Gliederung

Background and aim: Since 1996, a net of regional Pharmacovigilance Centers has been developed in Germany. Among the major objectives is the identification of serious ADRs in outpatient care leading to hospital admission.

Results: There were 6168 serious ADRs with at least a severity level of 4 according to Hartwig in 5686 patients. The mean age of patients was 70.06 (SD=15.72) years and 3440 (60.50 %) were female. The most common ADRs were gastrointestinal ulcers and bleedings (22.76 %), hypoglycemia (14.96 %) and bradycardia (6.71 %). The proportion of fatal ADRs was 1.32 % and the most frequently type of ADR was Type A (88.31 %). The five drugs most commonly imputed were ASA (1208), phenprocoumon (715), digitoxin (529), diclofenac (406) and human insulin fast-acting (378). Ten drugs accounted for 39.30 % of all ADR-related hospital admissions. The incidences of ADR related hospital admissions for certain drug groups and drugs based on ATC code will be presented, too.

Conclusion: It is highly relevant to learn that the majority of serious ADRs leading to hospital admission are well known and that the imputed drugs are marketed since very many years. It is widely accepted that many of these ADRs are preventable. The results of this study emphasize the value of this type of pharmacovigilance for the promotion of the safe use of drugs and patient safety. Routine pharmacovigilance monitoring of hospital admissions allows identifying the risks that agencies for patient safety need to know to act properly and in time.